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Quality of Labour Epidural Analgesia With Intrathecal Morphine as a Component of Combined Spinal Epidural

NCT06572241 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2026-04-01

No results posted yet for this study

Summary

Neuraxial analgesia has shown to be the gold standard for effective labor pain relief, offering numerous benefits including enhanced pain control and maternal satisfaction. The methods to achieve neuraxial analgesia include lumbar epidural (LE), and combined spinal epidural (CSE). While LE may not consistently provide optimal pain relief, leading to frequent maternal requests for supplemental analgesics, CSE presents a promising advancement. This is due to the rapid onset of pain relief from intrathecal components, complemented by the longer-lasting effects of epidural medications. Intrathecal drugs have demonstrated the ability to offer more symmetrical blockades compared to epidurally administered medications. Nonetheless, some clinicians remain cautious about CSE due to the potential for increased pain when transitioning from spinal to less effective epidural analgesia. Long-acting opioids like morphine in the intrathecal space may mitigate this problem by providing transitional analgesia to the laboring parturient.

The primary aim of this randomized controlled trial is to provide evidence of whether the addition of 100 mcg of morphine in the intrathecal (spinal) component of CSE reduces the rate of breakthrough pain during labor.

Conditions

  • Labor Pain

Interventions

DRUG

Intrathecal morphine

morphine 100 mcg, included in the intrathecal component of combined spinal epidural (CSE).

OTHER

Saline solution (placebo)

normal saline 0.2 ml added to the intrathecal component of combined spinal epidural (CSE).

Sponsors & Collaborators

  • Samuel Lunenfeld Research Institute, Mount Sinai Hospital

    lead OTHER

Principal Investigators

  • Naveed Siddiqui, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-20
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06572241 on ClinicalTrials.gov